SARS-CoV-2 vaccination response in patients with haematological disease
- Conditions
- diseae of bloodhematological diseaselymph and bone marrow10018849
- Registration Number
- NL-OMON52047
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
all of the following
criteria:
* Currently treated, previously treated and non-treated patients
diagnosed with the hematological malignancy multiple myeloma (including MGUS)
chronic lymphocytic leukemia and non-Hodgkin lymphoma.
Previously treated patient; is defined as: treatment <; 6 months before
vaccination in patients that obtained a complete remission. Exceptions (no time
restriction for last treatment) are patients with palliative treatment for
ongoing haematological malignancies and patients after autologous and
allogeneic stem cell transplantation.
* Patients who are scheduled for and will undergo SARS-CoV-2
vaccination.
* Aged * 18 years.
* Written informed consent.
* Inclusion is irrespective of previously proven or possible (based on
symptoms) COVID-19
excluded from participation in this study:
* Patients previously vaccinated for SARS-CoV-2.
* Patients who have senile dementia, mental impairment or any other psychiatric
disorder that prohibits the patient from understanding and giving informed
consent.
* Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>3.6.1 primary endpoints<br /><br>Presence of Anti-SARS-CoV-2 S-protein specific antibodies one month after<br /><br>vaccination (yes/no) of hematological patients that were seronegative for these<br /><br>antibodies before vaccination. </p><br>
- Secondary Outcome Measures
Name Time Method